Comparison of Aerosol Inhalation and Intravenous Glucocorticoid in the Treatment of Severe AECOPD

NCT06189586 | Unknown DMC

• 1 other identifier: 130064
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of aerosol inhalation and intravenous glucocorticoid in the treatment of severe AECOPD-------Multicenter, prospective, randomized, controlled clinical study

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Keywords

severe AECOPD; aerosol inhalation and intravenous glucocorticoid

Outcome Measures

Primary Outcomes (1)

• Relevant indexes after treatment

  Changes in blood gas indexes (oxygenation index, arterial partial pressure of carbon dioxide, pH value) of patients with respiratory rate, blood pressure, heart rate changes

  The day of admission, day one, day two, day three, day five, day seven, day ten

Study Arms (2)

Nebulized inhalation group

ACTIVE COMPARATOR

2 mg budesonide suspension for inhalation, nebulized inhalation for minutes,administered 4 times a day for 5 consecutive days.

Drug: aerosol inhalation of glucocorticoids

Intravenous hormone group

ACTIVE COMPARATOR

40mg sodium methylprednisolone succinate for injection(dissolved in 0.9% saline or5% glucose injection 50ml), intravenous infusion for 30 minutes, once a day for 5 consecutive days.

Drug: intravenous injection of glucocorticoids

Interventions

aerosol inhalation of glucocorticoids DRUG

Patients with severe AECOPD were continuously recruited from the care unit of Respiratory and Critical Care Medicine Department of the First Hospital of Jilin University to conduct a randomized cohort study, which was divided into aerosol inhalation group and intravenous glucocorticoid group. Subjects in the intravenous hormone group received 40mg methylprednisolone (dissolved in 0.9% normal saline /5% glucose injection 50ml) intravenously once a day. It lasts for 5 days. The atomized inhalation

Nebulized inhalation group

intravenous injection of glucocorticoids DRUG

Patients with severe AECOPD were continuously recruited from the care unit of Respiratory and Critical Care Medicine Department of the First Hospital of Jilin University to conduct a randomized cohort study, which was divided into aerosol inhalation group and intravenous glucocorticoid group. Subjects in the intravenous hormone group received 40mg methylprednisolone (dissolved in 0.9% normal saline /5% glucose injection 50ml) intravenously once a day. It lasts for 5 days. The atomized inhalation

Intravenous hormone group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Patients with AECOPD requiring hospitalization or emergency treatment (COPD acute attacks combined with respiratory failure were eligible). (2) 18 years of age ≤80 years of age (3) Patients and their families are willing to participate in clinical research and sign informed consent.

You may not qualify if:

• Combined with tuberculosis.
• Combined bronchiectasis.
• complicated with definite infectious diseases.
• PCT≥0.5ng/ml or CRP≥30mg/L.
• Serious injury combined with other organ functions
• Contraindications to other glucocorticoid use.
• Concomitant bronchial asthma or positive bronchodilation test

Sponsors & Collaborators

• Dong Yang: lead
• Jilin University: collaborator

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Study Officials

• Dan Li, Doctor

  The First Hospital of Jilin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assisted Investigator

Model Details: Description for medicine or protocol of treatment in detail: Dosing regimen: 1. Intravenous hormone group: 40mg sodium methylprednisolone succinate for injection(dissolved in 0.9% saline or5% glucose injection 50ml), intravenous infusion for 30 minutes, once a day for 5 consecutive days. 2. Nebulized inhalation group: 2 mg budesonide suspension for inhalation, nebulized inhalation for minutes,administered 4 times a day for 5 consecutive days.

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 3, 2024
• Study Start: October 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: July 31, 2025
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)